Rheumatoid ArthritisPhase 2NCT03193957
An Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis
A Phase 2 study testing Etanercept and Autoinjector in people with Rheumatoid Arthritis, run by Samsung Bioepis Co., Ltd. at 1 site in Poland.
Trial summary
A study comparing the usability of the Autoinjector and Pre-filled Syringe of SB4 in Subjects with Rheumatoid Arthritis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Etanercept and Autoinjector
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 15 May 2017to 25 Sep 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects are male or female aged 18-55 years at the time of signing the informed consent form.
Who cannot join
- Have been treated previously with monoclonal antibody agent including any tumour necrosis factor inhibitor except SB4.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis
A study comparing the usability of the Autoinjector and Pre-filled Syringe of SB4 in Subjects with Rheumatoid Arthritis.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Etanercept, Autoinjector
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
Etanercept PFS and Autoinjector
AutoinjectorDevice
Autoinjector
| Study group | Role | What they receive |
|---|---|---|
| SB4 | Experimental | SB4 (etanercept) 50 mg/mL Receives: Drug: Etanercept; Device: Autoinjector |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Injection site pain score at immediately post injection (within 1 minute)
The change in injection site pain score at immediately post injection (within 1 minute) using an 11-point visual numeric scale
Measured: at Week 1 and Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start15 May 2017
- Primary completion3 Aug 2017
- Study completion25 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Bioepis Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193957
- Sponsor's protocol ID
- SB4-G21-RA
- Status last verified
- Jul 2017
- First submitted
- 19 Jun 2017
- Last updated
- 13 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rho YH, Rychlewska-Hanczewska A, Sliwowska B, Kim TH. Usability of Prefilled Syringe and Autoinjector for SB4 (An Etanercept Biosimilar) in Patients with Rheumatoid Arthritis. Adv Ther. 2019 Sep;36(9):2287-2295. doi: 10.1007/s12325-019-01027-z. Epub 2019 Aug 1.
PubMed 31372961
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03193957
- Acronym / sponsor ID
- SB4-G21-RA
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Samsung Bioepis Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 May 2017 (actual)
- Primary completion
- 3 Aug 2017 (actual)
- Study completion
- 25 Sep 2017 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study comparing the usability of the Autoinjector and Pre-filled Syringe of SB4 in Subjects with Rheumatoid Arthritis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SB4 | Experimental | Drug: Etanercept, Device: AutoinjectorSB4 (etanercept) 50 mg/mL |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects are male or female aged 18-55 years at the time of signing the informed consent form.
Key exclusion criteria (1 listed)
- Have been treated previously with monoclonal antibody agent including any tumour necrosis factor inhibitor except SB4.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtanerceptEtanercept PFS and Autoinjector | Drug | SB4 |
| AutoinjectorAutoinjector | Device | SB4 |
Primary outcome
The change in Injection site pain score at immediately post injection (within 1 minute)
Time frame: at Week 1 and Week 3
The change in injection site pain score at immediately post injection (within 1 minute) using an 11-point visual numeric scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Derived from this study: PubMed 31372961Rho YH, Rychlewska-Hanczewska A, Sliwowska B, Kim TH. Usability of Prefilled Syringe and Autoinjector for SB4 (An Etanercept Biosimilar) in Patients with Rheumatoid Arthritis. Adv Ther. 2019 Sep;36(9):2287-2295. doi: 10.1007/s12325-019-01027-z. Epub 2019 Aug 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Etanercept and Autoinjector in people with Rheumatoid Arthritis, run by Samsung Bioepis Co., Ltd. at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in Injection site pain score at immediately post injection (within 1 minute) (time frame: at Week 1 and Week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03193957, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2017.